Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
The goal of this clinical research study is to evaluate fluorescence imaging (including a new handheld device), widefield fluorescence imaging, and/or point spectroscopy imaging methods that may help doctors monitor patients at an increased risk of developing an oral cancer, including those with pre-cancerous lesions in the mouth.
The overall objective of this exploratory study is to evaluate whether widefield multispectral imaging and/or point spectroscopy can assist in follow-up surveillance of patients with high risk for development of oral cancer including those with premalignant lesions in the oral cavity. Digital images obtained using various light wavelength combinations and spectroscopy of specific lesions will be used to examine patients at high risk for oral cancer during routine clinical follow-up examinations. Data will be correlated with standard clinical examination, development of dysplasia and invasive carcinoma, and pathological evaluation of biopsies when available.
The specific aims of the study are:
- To compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
- To assess whether the multispectral images and spectroscopic data provide any added benefit to assist clinicians in surveillance of high risk patients.
This will be an exploratory study designed to obtain images and/or spectroscopic data over time during routine follow-up surveillance of patients at high risk to develop oral cancer. We will investigate based on the following hypotheses:
- The optical properties of epithelial tissue are altered due to biochemical and architectural changes occurring during malignant conversion. These alterations can be optically detected and used for diagnosis.
- The human eye can better distinguish alterations in optical properties between non-neoplastic, dysplastic and malignant oral mucosa with the assistance of fluorescence and reflectance imaging.
Procedure: Portable Spectroscopy System
Procedure: Multispectral Digital Microscope
Procedure: Fast Excitation-Emission Matrix System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Fluorescence & Reflectance Imaging to Detect Oral Neoplasia|
- Evaluate Portable Spectroscopy System (PS2), Multispectral Digital Microscope (MDM), + Fast Excitation-Emission Matrix (EEM) Imaging Methods [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: PS2 + MDM + Fast EEM4
PS2 imaging system that shines different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light. MDM imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera. Fast EEM4 - Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed.
Procedure: Portable Spectroscopy System
Imaging system that shines different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light.
Other Name: PS2Procedure: Multispectral Digital Microscope
Imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera.
Other Name: MDMProcedure: Fast Excitation-Emission Matrix System
Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed.
Other Name: Fast EEM4
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00542373
|Contact: Ann M. Gillenwater, MD||713-792-6920|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Ann M. Gillenwater, MD|
|Principal Investigator:||Ann M. Gillenwater, MD||M.D. Anderson Cancer Center|